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AI Has Arrived In Biotech CMC Amid Patchwork Governance

AI is surfacing within regulatory and CMC workflows at a vigorous pace. Unfortunately, in small and midsize biotechs, it's happening faster than governance can keep up.

Avoiding Common Pitfalls In CDMO–Sponsor Relationships Through Integrated Execution Models
The Future Of Continuous Is Integrated Manufacturing: The 4 Misconceptions About A Lean Process

GUEST COLUMNISTS

CDMO Selection: Start With The Relationship, Not The RFP
Friction often comes from unspoken expectations. Before production begins, treat the combined sponsor-CDMO group as one extended team and intentionally make “how we work together” visible.
Why FAT Should Confirm Alignment, Not Reveal Its Absence
In many aseptic fill/finish projects, the factory acceptance test (FAT) has become the first true integration test of the entire project. That is a problem. Here's how to flip that mindset.
What Reliance, Annex 1, And AI Mean For The Future Of GMP
EMA’s Brendan Cuddy explains how regulators are adapting oversight to global supply chains, new technologies, and growing operational complexity.
Applying Contamination Control By Design: A Practical Guide For CDMOs
This article addresses the three contamination control challenges that are specific to the CDMO environment, provides five practical steps any organization can act on now, and more.
Rethinking CQV In A Digital, Agile Manufacturing Landscape
While commissioning, qualification, and validation (CQV) remains foundational, the way it is planned and executed must evolve to keep pace with modern manufacturing realities.
Will FDA's One-Day Inspection Pilot Stand The Test Of Time?
FDA's complementary pilot could help weed through a persistent examination backlog, but uncertainty and upheaval in leadership at the top puts its future in question.
A Multi-Agent Audit Intelligence Framework For CDMO Quality Oversight
A Takeda quality executive demonstrates how a team of AI agents uses synthetic data to provide decision support ahead of CDMO audits.
Why Contamination Control By Design Should Matter To Your CDMO
EU GMP Annex 1 mandates a documented contamination control strategy, and FDA expectations are substantively equivalent. Let's look at why CDMOs are disproportionately exposed.

PHARMA OUTSOURCING WHITE PAPERS

A Shift Towards Biofluorescent Particle Counters In Manufacturing
Sterility in injectable drug manufacturing is vital for patient safety and efficiency. Discover how biofluorescent particle counters revolutionize contamination control, regulatory compliance, and operational excellence in modern pharma.

Unlocking Durable Allogeneic Cell Therapy
Advances in genome engineering and immune evasion are enabling scalable, durable allogeneic cell therapies, overcoming rejection challenges and expanding potential treatments across diverse diseases.
Efficient Late-Stage Development Of Biologics
Reducing biologics manufacturing costs requires strategic late-stage process development, yield optimization, scale-up, and raw material substitution—all while maintaining product quality and regulatory compliance.
The Importance Of Quality In Raw Material Selection
Learn how to select high-quality raw materials for cell-based manufacturing in this exploration of the criticality of raw materials, from preclinical development to commercialization.
Viral Disinfectant Efficacy Studies: Key Guiding Factors And Design Elements
Achieving compliance and safety through Disinfectant Efficacy Studies (DES) is about adhering to regulations and committing to high standards of safety and quality of manufacturing operations.
Spray Dry Biologics For Oral Dosage Forms
Spray drying enables stable oral delivery of biologics by creating protective dry powders, improving bioavailability, stability, and targeted release compared with traditional formulation methods.